Brain and Central Nervous System Tumors, Thromboembolism
Conditions
Keywords
thromboembolism, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Brief summary
RATIONALE: Patients with gliomas may be at risk for developing blood clots. Learning about the risk factors for developing blood clots may help doctors plan better treatment for gliomas. PURPOSE: This clinical trial is studying risk factors for developing blood clots in patients who are undergoing cancer treatment for newly diagnosed gliomas.
Detailed description
OBJECTIVES: Primary * Determine the overall hazard rate of first venous thromboembolism per person-year of follow-up in patients undergoing antineoplastic therapy for newly diagnosed high-grade gliomas. * Correlate ABO blood type with incidence of venous thromboembolism in these patients. * Correlate factor VIII level with incidence of venous thromboembolism in these patients. Secondary * Determine the overall and individual incidence rate of thromboembolism in these patients. * Correlate clinical variables, such as type of antineoplastic treatments, Karnofsky performance status, and type of tumor, with incidence of venous thromboembolism in these patients. * Correlate demographic factors, such as age, with incidence of venous thromboembolism in these patients. OUTLINE: This is a pilot, multicenter study. Patients undergo blood collection for blood typing (if not already obtained) and factor VIII and C-reactive protein levels at baseline. Patients are followed to obtain information on their Karnofsky performance status, treatment they receive for their brain tumor, and occurrence of any thrombotic events (e.g., pulmonary embolism or deep-vein thrombosis). Patients are followed every 28 days until the development of thrombotic events, after which they are followed every 2 months for survival. PROJECTED ACCRUAL: A total of 107 patients will be accrued for this study.
Interventions
OTHERlaboratory biomarker analysis
OTHERphysiologic testing
PROCEDUREmanagement of therapy complications
Sponsors
National Cancer Institute (NCI)
North American Brain Tumor Consortium
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed malignant brain tumor * Supratentorial grade III or IV astrocytoma of 1 of the following types: * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Glioblastoma multiforme * No prior thrombotic event PATIENT CHARACTERISTICS: Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy or biologic agents, including immunotoxins, immunoconjugates, antisense therapy, peptide-receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphocyte-activated killer cells, or gene therapy, for the brain tumor Chemotherapy * No prior chemotherapy for the brain tumor except polifeprosan 20 with carmustine implant (Gliadel wafer) Endocrine therapy * No prior hormonal therapy for the brain tumor except glucocorticoids Radiotherapy * No prior radiotherapy for the brain tumor * No prior cranial irradiation Other * No concurrent chronic anticoagulation therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thrombosis-free survival as assessed by objectively documented deep vein thrombosis or pulmonary embolism | until dvt or death |
Secondary
| Measure | Time frame |
|---|---|
| ABO blood group association with venous thromboembolism (VTE) factor VIII activity and VTE as assessed by laboratory test result at study entry | on study |
Countries
United States
Outcome results
None listed